About this Author

College chemistry, 1983

The 2002 Model

After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases.
To contact Derek email him directly: derekb.lowe@gmail.com
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November 1, 2010

Are Genes Patentable Or Not?

Posted by Derek

There seems to be some disagreement within the US government on the patentability of human genes. The Department of Justice filed an amicus brief (PDF) in the Myriad Genetics case involving the BRCA genes, saying that it believes that genes are products of nature, and therefore unpatentable.

But this goes opposite to the current practice of the US Patent and Trademark Office, which does indeed grant such patents. No lawyers from the PTO appear on the brief, which may be a significant clue as to how they feel about this. And at any rate, gene patentability is going to be worked out in the courts, rather than by any sort of statement from any particular agency, which takes us back to the Myriad case. . .

There is interesting and cogent criticism of the science (or lack of understanding thereof) in the DOJ brief in the Patent Docs blog: (http://www.patentdocs.org/2010/10/doj-tries-to-be-all-things-to-all-constituencies-in-myriad-amicus-brief.html).

The gene patenting situation is a strong and valid example of the (normally wrong) whine that biotech/pharma rips off the public for the fruits of taxpayer-funded research. The big and expensive studies establishing certain genes as biomarkers/diagnostics for certain diseases come almost universally from public institutions/NIH grants. And it's not like a diagnostic test requires a ton of preclinical development work and $800m in clinical trials. So really there is absolutely no reason to protect these.

I'm all for patenting a way of "doing something" but not just the idea of "this is why I know something". If you want to demonstrate how a newly discovered gene sequence can be applied to developing a diagnostic test, more power to you. Others should not be able to copy your test. But your claims that are valid should be those that you developed that would make the test feasible, not just the knowledge base that nature provided that you uncovered.

I feel uneasy siding with the ACLU about anything, but I will here since I feel that such broad claims are crazy.

It is interesting that the case only challenges a subset of the claims in the Myriad patents, but it is generally viewed as invalidating all of their patents. As such the appeals process might narrow the victory, but I don't expect a full reversal.

Proteins and natural products both involve an invention - while the objects exist in nature, their use for a particular purpose does not, and generally neither do their methods of isolation or manufacture. Hence, there's a direct element of human ingenuity and invention in their use.

The existence and potential use of a gene, on the other hand, rather than its isolation or generation in a form useful for diagnostics, seems to be what's claimed. In that case, the "inventor" doesn't seem to have added anything to the gene that it doesn't do naturally other than the knowledge that the gene does it. Patents aren't supposed to be for knowledge, but for implementations and inventions.

Hap - the patent in question did not claim the gene, but rather the isolated gene. The isolation of a gene is generally held to render it patentable. for instance, you could not have a patent to taxol, but you could have a claim to isolated taxol, or a dosage form containing taxol...

my understanding of the myriad case was that the diagnostic test for determining if a patient had the mutation likely to lead to breast cancer was some sort of PCR, which produces the isolated gene, and thus falls within the scope of the claim. thus myriad was able to charge an arm and a leg to anyone who wished to know if they had the BRCA1 mutation

the court's decision recognized the patentability of isolated natural products, and distinguished DNA on the grounds that it was more than a simple molecule, it was also "information."

congress could carve out a special exemption for dna, but i don't see how this decision could stand otherwise

Diseases are natural. Genes are natural and reside within the cells of people. If a mutation in a gene causes a disease, finding that mutation is an incredibly useful discovery. However, that discovery does not require innovation. It may require ingenuity and creativity in looking in a certain place, but nothing was created or modified. It was not applied in a novel fashion to be used as a treatment. Therefore, the gene, or more specifically the genetic test for the gene should not be patentable.

The DOJ's brief is largely untethered from the reality of the science and the patent claims. So is the ACLU's. It's hard to fathom why this case has even been taken up. They couldn't even find a plaintiff who had credibly been harmed. Of course the sound bite that "they are patenting our genes" is a great rallying cry, it's not what is actually claimed.

@Milkshake, no it won't. That issue has been dealt with by the University of Rochester (COX2) and Ariad v. Lilly (NFkB) cases. This is completely different.

Patenting PCR for the detection of BRCA mutations seems like patenting the use of visual wavelengths for the detection of automobiles and charging people for driving - you didn't develop the tool, and its application to sequencing BRCA seems obvious. The primer sequences are not so obvious, but the ability to prevent sequencing of the gene seems to bequeath ownership of the gene in practice to Myriad. Hence the "the patenting our genes" cry - it doesn't look a whole different in practice from what Myriad is actually doing.

A test based on the primers seems legitimately patentable as a direct invention. You don't need to make something new, you can figure out how to use something already present. The human ingenuity part is the key - you need to find something new and useful. Novel methods of detecting things are legitimate inventions, even if the detected objects exist in nature.

Hap - the Myriad decision did not, I don't believe, rule on whether the identification/isolation of BRCA1 would have been obvious (thus rendering it unpatentable) the question was whether isolated DNA was patent-eligible subject matter in the first place.

Don't hold me to the PCR issue, anything with a MW over ~1,000 makes me run for cover. I'm sure the claim read something like "isolated gene X," or "gene X, separated from its cellular environment" and the current technology for identifying mutations requires the isolation (or at least some degree of separation) of the gene from its natural cellular environment, whether by PCR or other technique.

I just have to walk next door to our cancer outpatient building to find a whole stack of people that have been harmed. Myriad's patent enables them to charge what the monopoly market will bear, consistent with their greed not causing them a major PR disaster. That works out to $2000+ per test. With today's DNA sequencing technology, that test should cost 10x less.

@Hap: The United States, through the DOJ, is always permitted to express its views to an appellate court as an amicus pursuant to Federal Rule of Appellate Procedure 29(a).

As for why it's the DOJ and not the PTO, it's fairly simple -- the PTO is not a party to this litigation. The PTO granted the patent, but the only cases in which the PTO has an interest is when the case is being appealed after the Board of Patent Appeals and Interferences denies a patent (all of the cases begin with "In re" at the Federal Circuit level). The PTO could file its own amicus brief, but it would need to petition the court to do that.

And as for disagreement between the Executive generally and specific agencies, it's not at all uncommon for views to differ. For example, the FTC has sought Supreme Court review of circuit court decisions reversing the Commission's sanctions for pharmaceutical reverse-payment settlements a couple of times, but the Solicitor General has filed amicus briefs encouraging the Court not to grant cert in both instances.

@Cancer Genetics, you're right that there is an economic cost. I overstated my point. The plaintiffs are barely credible because they seem to have some only some vague idea that if the patents didn't exist they would do things differently. This is really a side argument about standing, but it makes one wonder what the motive for the litigation is.

But if the rationale is cost then there should not be any right to exclude infringers from copying any diagnostic or therapeutic. Just because you could copy something for less if there weren't a patent doesn't mean that the patent should be invalid.

I'm sorry but where is this feeling of loyalty to the almighty IP lord coming from? Patents aren't some philosophical, moral ideal before which though shalt kneel. They are a tool to help the economy reach an optimal level of productivity, to benefit society to the greatest. Drug patents are a good thing because the cost and risk of making drugs would make it a terrible business to get into if you couldn't protect your ideas. Is anyone willing to make the argument that limiting the ability to "patent genes" for diagnostics is going to diminish the benefit to society? Does anyone think the the final product on the market, of, say, a Colon cancer stool DNA test, would be better if companies patented the genes on these tests? On the contrary, rejecting these patents would lead to increased competition to make the absolute best DNA test on the market.

@ ronathan richardson: I think they may be devotees of Kevin Noonan who never met a patent he didn't like, and writes the useful (but very wrong-headed) PatentDocs blog (and is also one of the authors of an amicus brief supporting Myriad, so there's an obvious conflict of interest).

Going by the article, I am a little confused as to the position of an isolated DNA which has to function as a diagnostic tool is concerned. Will I be right if I canvass for the position that to be useful in a test tube for the purposes of diagnosis, an isolated DNA must have both the same information content and the same function as the sequence in your body, in which case the DNA cannot command protection.

In my point of view, a subject that is patented should be an invention. It shouldn’t be a naturally occurring substance. In this case those who wants to patent a gene, only isolates the gene in a form where it is useful for diagnostic purposes. It shows that there is no any sort of addition or modification done to the gene. If there is modification done to the gene by the inventor then that’s what they can patent but not just a naturally occurring gene.